Augmedics Files for IPO: Pioneering AR Spine Surgery with $143.6M Raised and FDA-Cleared xvision Platform

“Breakthrough Advances Will Revolutionize Surgical Techniques”

Augmedics states this on the homepage of its official website. Augmedics is a medical technology innovation company focused on using AR technology to improve spinal surgery, headquartered in Chicago, USA, and founded by Nissan Elimelech and Tim Murawski from Israel.

Augmedics’ mission, and the original intent behind the development of its flagship xvision Spine System, is to empower surgeons with greater control during procedures by creating advanced technologies that meet their needs and integrate seamlessly into their existing workflows.

The xvision Spine System is a wearable AR navigation system that enables surgeons to “see through” patients’ anatomical structures during surgery, accurately guiding surgical instruments and implants. xvision aims to revolutionize surgical procedures by instilling technological confidence into the surgical workflow, enhancing surgeons’ access to cutting-edge technology, and helping physicians perform their tasks as effectively and safely as possible.

With the aging of the population, the incidence of degenerative spinal disabilities has increased accordingly, which will increase the demand for surgical treatment of such disabling diseases. Driven by the rapid development of minimally invasive surgical techniques, the demand for spinal surgery has shown a high-growth trend. A report by iData Research titled “Spine Surgery Statistics to Watch in 2019 – Motion Preservation Gaining Popularity” shows that approximately 1.62 million instrumented spinal surgeries are performed annually in the United States alone.

In contrast to the high growth demand, treatment outcomes remain suboptimal due to a lack of advanced technologies. Spinal surgery is one of the fastest-growing surgical categories; however, its high frequency obscures the complexity of these procedures and the occasionally unsatisfactory therapeutic results. The local anatomy of the spine is intricate and closely adjacent to critical blood vessels and nerves, thereby imposing higher demands on precision in spinal surgery. Traditional spinal surgeries rely heavily on surgeons’ experience and are prone to issues such as inaccurate screw placement, resulting in significant surgical trauma and numerous complications. The article “Accuracy of lower cervical pedicle screw placement with assistance of distinct navigation systems: a human cadaveric study” points out that the probability of deviation exceeding 1 mm during pedicle screw placement without technological assistance can reach 37.5%. Furthermore, in their article “Progress in the Application of Surgical Robots in Spinal Surgery,” Zhang Yuxuan, Wang Hongli, and others note that even with various auxiliary methods such as preoperative CT, intraoperative fluoroscopy, and navigation, the failure rate of screw placement remains as high as 4.1%–28.9%.

Augmedics’ xvision Spine System effectively addresses this issue. In December 2019, Augmedics announced that it had received U.S. Food and Drug Administration (FDA) 510(k) clearance and launched the xvision Spine System in the United States.

Augmedics has established an AR-based navigation platform through xvision, leveraging augmented reality technology to provide surgeons with “X-ray vision” and improve the process and outcomes of spinal surgeries. xvision can be used for open and percutaneous spinal surgeries involving the cervical, thoracic, lumbar, sacral, and iliac regions. These procedures include spinal decompression, spinal fusion, discectomy, laminectomy, and pedicle screw fixation. Furthermore, xvision demonstrates strong compatibility, as it is compatible with any spinal pedicle screw implants and any intraoperative CT scanner. By enabling precise positioning and navigation for the implantation of spinal screws and other instruments, xvision enhances surgical success rates and stability while reducing procedural complexity and difficulty. It offers distinct advantages in effectively shortening operative time, improving surgical efficiency, and minimizing surgical risks and radiation exposure.

The xvision Spine System consists of a transparent near-eye display headset and a conventional navigation system, which can accurately determine the position of surgical instruments and overlay them onto the patient’s CT images in real time. Meanwhile, the 3D transparent view enables visualization of cortical boundaries, allowing surgeons to “see through” the skin and tissue to observe the patient’s anatomy and adjust according to their perspective, thereby facilitating accurate real-time navigation of instruments and implants.

Unlike traditional navigation systems, xvision features a built-in tracker and retinal display, eliminating the need for surgeons to repeatedly shift their gaze to auxiliary screens during procedures and thereby avoiding associated distractions. The transparent AR display projects 3D anatomical structures and instrument details onto the surgeon’s retina without obstructing the surgical field, thus providing enhanced visualization and accuracy during spinal surgeries.

xVision is a wireless system that requires no cables or external devices, allowing surgeons to move freely within the operating room. Its built-in high-speed processor enables seamless visual tracking, ensuring image clarity and stability. Additionally, the personalized headset can be adjusted to each user’s visual acuity, head size, and shape, providing optimal comfort and field of view for a truly customized fit. Furthermore, xVision facilitates minimally invasive spinal surgery, enabling surgeons to operate through smaller incisions with less tissue damage. This helps reduce patient blood loss, infection risk, postoperative pain, and complications, while shortening hospital stays and recovery time.

xvision is sometimes described as “X-ray-like.” In reality, it is based on CT scans of the patient’s spine, which are then digitized and calibrated to provide a view from the perspective of the surgeon wearing xvision. This can replace fluoroscopy in minimally invasive procedures, where the patient’s back does not need to be opened. Furthermore, while fluoroscopy is an X-ray-based process, xvision enables surgeons to visualize the patient’s anatomy and the position of surgical instruments without using a fluoroscope, effectively avoiding radiation exposure and better protecting the health of both doctors and patients.

On June 8, 2020, Augmedics’ xvision Spine System was successfully used for the first time in a spinal fusion surgery in the United States. The procedure was performed and completed successfully at Johns Hopkins Hospital. Located in Baltimore, Maryland, Johns Hopkins Hospital is a renowned general hospital and one of the largest teaching hospitals in the United States. It was the first hospital in the U.S. to adopt the xvision Spine System and the first to complete 4,000 xvision-guided procedures. Its surgeons have utilized the xvision system for various types of spinal surgeries, including lumbar decompression, fusion, and pedicle screw fixation, as well as cervical decompression, fusion, and artificial disc replacement.

In September 2022, Augmedics announced the completion of its 2,000th xvision case. John Stevenson, the neurosurgeon and spine specialist who performed the 2,000th procedure, has been practicing as a spine surgeon for nearly 25 years and has used almost every type of navigation system available on the market. He believes that the accuracy of xvision not only ensures patient safety but also has transformed his approach to spinal surgery. Just five months later, Augmedics announced again that the xvision Spine System had been used to treat more than 3,000 patients. The 3,000th procedure was performed by Safdar Khan, Director of Orthopedic Spine Surgery at The Ohio State University Wexner Medical Center (Columbus, Ohio, USA). He stated that xvision makes screw placement easier, safer, and more accurate while maintaining the ability to teach residents and colleagues.

In the same week that the Series D funding announcement was released, Augmedics achieved a record-breaking milestone—the 4,000th U.S. patient received treatment with xvision. Currently, xvision has reached users in 21 U.S. states and facilitated the implantation of more than 20,000 pedicle screws. The xvision system has demonstrated an overall percutaneous screw placement accuracy of 99.1%. Multiple patient studies have consistently shown that xvision achieves pedicle screw placement accuracy ranging from 97% to 100%. This significantly enhances precision and helps avoid nerve or vascular injury.

On March 8, 2023, Augmedics announced the launch of new FDA-cleared features and indications for its xvision Spine System. The new features include AI-powered image enhancement and new customizable views, further expanding xvision’s advanced visualization and customization capabilities. Additionally, the new cervical and iliosacral indications, combined with existing thoracic, lumbar, and sacral indications, extend xvision’s lesion clearance to nearly the entire spine, enabling surgeons to benefit from xvision navigation advantages in posterior cervical and pelvic approaches. This milestone marks the largest indication expansion for xvision since its commercial launch and lays the technical foundation for future platform development.

On June 27, 2023, Augmedics announced the successful completion of an $82.5 million Series D financing round. The round was led by Dallas-based CPMG, with Evidity Health Capital joining as a syndicate partner. Existing investors, including HIG Capital, Revival Healthcare Capital, and Almeda Ventures, also participated. According to Crunchbase, Augmedics’ total funding has reached $143.6 million. These funds will support Augmedics in accelerating its commercialization efforts, driving iterative advancements in its next-generation platform, and enabling the large-scale adoption of xvision technology.

In 2022, the global market size for spinal surgery equipment reached RMB 45.314 billion. By 2028, the global market size is projected to reach RMB 59.199 billion, with an estimated compound annual growth rate (CAGR) fluctuating around 4.48%. This highlights the vast potential of the spinal surgical instrument market. Regarding future plans, Kevin Hykes, CEO of Augmedics, stated that the company has significant long-term interest in developing applications beyond spinal surgery. He noted that the company sees opportunities in other musculoskeletal areas as well as in cranial surgery, where accurate images of soft tissues surrounding bones can be obtained using CT and MRI scans.